Terminated

Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use Only.

FDA Recall Z-1574-05 · Posted 2005-09-21

Recalling FirmPower Surgical Solutions

Recall StatusTerminated

Product CodeGET

Date Initiated2005-09-01

Date Terminated2007-07-25

Product Quantity3,522,710 units

Reason for Recall

Potential compromise of sterile packaging for disposable dissecting tools.

Firm Action

Firm notified consignees by letter on 9/1/2005.

Root Cause

Other

Distribution Pattern

Nationwide and the following foreign countries: Aruba, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, S. Africa, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, U.S. Virgin Islands, Uae, United Kingdom, Uruguay, and Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex · 2002-03-18 K953433MIDAS REX TELESCOPING SYSTEMMidas Rex Pneumatic Tools, Inc. · 1995-09-15 K953432ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLSMidas Rex Pneumatic Tools, Inc. · 1995-09-14 K952463GS & GS20 SURGICAL TOOL SYSTEMMidas Rex Pneumatic Tools, Inc. · 1995-07-17 K900388MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINESMidas Rex Pneumatic Tools, Inc. · 1990-05-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.